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NCT07324902
1. Introduction Lipoprotein(a), or Lp(a), is a type of lipoprotein that is structurally similar to LDL (low-density lipoprotein) but carries an additional protein called apolipoprotein (a). 2. Purpose of the Study The primary purpose of this study is to investigate the effect of Lp(a) levels on arterial stiffness, endothelial function, and left atrial (LA) and left ventricular (LV) deformation over a 12-month follow-up period. Secondarily, the study will investigate: * a) The incidence of major adverse cardiovascular events (MACE), including cardiovascular death, acute myocardial infarction, and acute stroke. * b) The correlation between MACE incidence and parameters of arterial stiffness, endothelial function, and LA/LV deformation. * c) The levels of oxidative load markers. 3. Materials and Methods This observational study will include adults aged 18-75 years (regardless of gender) who visit the outpatient clinics of the 2nd University Cardiology Clinic at "Attikon" General Hospital. All participants will sign a consent form. A full medical history, clinical examination, and blood collection will be performed to determine levels of Total Cholesterol, LDL-C, HDL-C, triglycerides, and Lp(a) at each visit.. Participants will be divided into three groups: * Group A: Lp(a) ≥50 mg/dL with Total Cholesterol\<200 mg/dl * Group B : Lp(a) \<50 mg/dL. with Total Cholesterol\>200 mg/dl * Group C (Control): Lp(a) \<50 mg/dL. with Total Cholesterol\<200 mg/dl At each group n ≥ 100 participants are anticipated. Measurements at baseline, at 6 and at 12 months: * Arterial Stiffness: Determination of carotid-femoral pulse wave velocity (cf-PWV) using the Complior SP device and 24-hour pulse wave analysis with the Mobil-O-Graph device. * Endothelial Function: Measurement of the endothelial glycocalyx thickness of sublingual capillaries using a Sidestream Dark Field (SDF) camera (GlycoCheck). This is expressed through the perfused boundary region (PBR) index. * Cardiac Deformation: Use of two-dimensional strain (speckle tracking) to calculate the Global Longitudinal Strain (GLS) of the LV and LA strain. * Oxidative Load: Determination of malondialdehyde (MDA) and protein carbonyls (PCs) levels as markers of oxidative stress using spectrophotometric kits. Statistical Analysis: Comparisons regarding the changes in these markers over 6 and 12 months will be conducted between the three groups.
NCT05259046
The purpose of this study is to examine the effect of menaquinone-7 (MK-7) supplementation on cardiovascular, metabolic, and bone health.
NCT06506422
Randomized placebo-controlled clinical trial in a cohort of males (n=40) and females (n=40), 60-80 years of age, with the hypothesis that SGLT2 inhibition with empagliflozin (10mg/day for 12 weeks) reduces aging-related arterial stiffening.
NCT07319962
American football has become an increasingly popular sport in Türkiye, and one of the key determinants of success in this discipline is the development of strong aerobic and anaerobic exercise capacities. Previous research has examined arterial stiffness in various athletic populations, including endurance athletes, wrestlers, badminton players, volleyball players, and soccer players. These studies highlight the importance of detailed cardiovascular and hemodynamic evaluation to identify potential risk groups and to better understand sport-specific physiological adaptations. In sports requiring prolonged physical effort, maximal oxygen uptake is a major determinant of performance, underscoring the need to assess this parameter in elite athletic populations. Although a limited number of studies have investigated aerobic and anaerobic exercise capacities in American football athletes, no research to date has evaluated arterial stiffness or intercostal muscle oxygenation in this group. The present study aims to investigate arterial stiffness, intercostal muscle oxygenation, aerobic and anaerobic exercise capacity, and upper-extremity endurance in elite American football players compared with sedentary individuals. A cross-sectional study design will be used. Elite male athletes from the Gazi University American Football Team who volunteer to participate will be included, and their results will be compared with age- and sex-matched sedentary individuals. A total of 15 elite male athletes and 15 sedentary participants aged 18-30 years will be enrolled. All participants will undergo standardized assessments of arterial stiffness, intercostal muscle oxygenation, aerobic and anaerobic capacity, and upper-extremity endurance. Normality of variables will be assessed using visual inspection and the Kolmogorov-Smirnov and Shapiro-Wilk tests. Descriptive statistics will be reported as means, standard deviations, and 95% confidence intervals for normally distributed variables, and medians with interquartile ranges (25th-75th percentiles) for non-normally distributed variables. Frequencies and percentages will be used for categorical data. Between-group comparisons will be conducted using the independent samples t-test for normally distributed variables and the Mann-Whitney U test for non-normally distributed variables. Categorical variables will be analyzed using the chi-square test. A p-value of \<0.05 will be considered statistically significant.
NCT07311512
* Gum inflammation is called gingivitis. Gum disease, known as periodontal disease, is a long-term inflammation of the gums and bone around teeth, leading to tooth loss. Both gingivitis and periodontal disease are also linked to other health problems, including heart disease. Additionally, salivary proteins play a role in maintaining oral health. For example, a protective layer called the salivary pellicle (SP) forms on teeth after tooth brushing and helps defend against harmful bacteria. * Nitrate-reducing bacteria (NRB) are also present in saliva and play a role in oral and cardiovascular health by converting nitrate to nitric oxide (NO). This compound supports blood vessel health and overall cardiovascular function. Therefore, NRB's abundance is linked to lower blood pressure and improved cardiovascular health. * Standard treatments for gum disease include deep cleaning (also called professional mechanical plaque removal, or PMPR), and sometimes chlorhexidine (CHX) mouthwash is used with PMPR to help reduce mouth bacteria. However, while CHX is effective against plaque (a sticky film of bacteria on the tooth surface), it may reduce the activity of "nitrate-reducing" bacteria (NRB), which are important for producing nitric oxide (NO). * This study investigates the impact of deep cleaning (PMPR) with and without Chlorhexidine mouthwash on salivary and SP proteins, as well as blood vessel function, in people who have gum disease. By examining these links, the investigators aim to gain a deeper understanding of how oral care practices may impact overall health, particularly heart health.
NCT06817252
The goal of this clinical trial is to is to determine the effects of baked potato with the skin (BP) + nutrition education focused on adherence for a Mediterranean Dietary Pattern (MEDNE) on glycemic control, cardiometabolic health, and dietary quality in individuals with pre-diabetes from different demographic backgrounds. The main questions it aims to answer are: * Does BP+MEDNE contribute to improvements in indices of glycemic control, vascular function, blood lipids, inflammation/oxidative stress, and body composition? * Does BP+MEDNE contribute to improvements to overall dietary intake and quality? Researchers will compare BP+MEDNE to MEDNE alone to see if BP+MEDNE can improve glycemic control, cardiometabolic health, and dietary quality in individuals with pre-diabetes from different demographic backgrounds. Participants will: * Be asked to come to the study site initially for a Screening Study Visit to confirm eligibility. * Be asked to come the study site for a Pre-Baseline and Pre-12-Week Study Visit (one week prior to Baseline and 12-Week Study Visits) for placement of placement of a continuous glucose monitor and wearable devices to be removed at Baseline and 12-Week Study Visits. * Be asked to come to the study site for Baseline, 6- and 12-Week Study Visits for assessments of glycemic control and cardiometabolic health. * Be asked to complete 3-Day Food Records throughout the 12 week study period for assessment of dietary quality (5 total) * Receive pre-recorded MEDNE ( which can be accessed via computer device/ipad/smartphone) after Baseline and 6-Week Study Visits. * If randomized to the BP+MEDNE group, participants will receive pre-prepared baked potatoes with the skin for the 12-week study period (every 3 weeks) at Baseline and 6-Week Study Visits and asked to come to the study site for picking up the pre-prepared baked potatoes at weeks 3 and 9 of the study period.
NCT05943457
Migraine is a debilitating illness and a major cause of disability in the world. It is highly prevalent, especially among women. Vitamin supplementation is a potential therapeutic option for migraines that remains largely under-explored. Several studies have shown that people with migraine tend to have higher arterial stiffness than people without migraine. Vitamin K2 deficiency is an important mediator of arterial stiffness and calcification due to decreased carboxylation of matrix Gla protein (MGP). Supplementation reverses these changes and improves vascular health in patients with end stage renal disease according to previous studies. Therefore, vitamin K2 supplementation could serve a potential role in migraine patients. The purpose of the study is to test the effect of vitamin K2 on decreasing the frequency of migraine attacks and decreasing arterial stiffness. The population will be recruited from the neurology clinic at LAU Medical Center-Rizk Hospital and will constitute of adult patients. They will be randomized to receive either the supplement of vitamin K2 or a placebo for the duration of 6 months. Laboratory tests and arterial stiffness measurements will be done at the beginning, middle, and at the end of the study for comparison.
NCT04720690
Babies may be born appropriately grown for gestational age (AGA, \>10th centile) or small for gestational age (SGA, \<10th centile). Babies who are SGA and have evidence in utero of vascular compromise using antenatal doppler indices are classified as having fetal growth restriction (FGR). Babies with FGR are at increased risk of cardiovascular disease in adult life. Increased arterial stiffness and intima-media thickness are thought to mediate this risk in adults. It is not known how early in life these changes can be robustly detected. In addition, very little is known generally about how babies' hearts and arteries change in structure and function over the first year of life, whether affected by SGA or not. This study aims to understand if there are differences in cardiac and arterial structure and function between babies born AGA or SGA. Within the group of SGA babies, the study team will investigate whether FGR and maternal pre-eclampsia influence these measurements. The effects gestational age on these parameters will be studied within all groups: half of the babies recruited will be \<32 weeks gestational age (GA), and half will be ≥32 weeks GA. Study participants will have further measurements at 3-6 months of life to assess if cardiac and arterial structure and function change in babies over the first year of life. The study team will use the Vicorder device to measure arterial stiffness, and assess the feasibility of using this device in neonates. The Vicorder will also be used to measure cardiac output. The feasibility and validity of this device for this purpose will be investigated (Vicorder is not validated for cardiac output measurement in infants). Vicorder cardiac output results will be compared to echocardiography and bioimpedence technology (using the NICaS monitor). The study team will use ultrasound for arterial structure measurements of the carotid artery and aorta.
NCT06440369
Physical activity (PA) is essential for the prevention and treatment of chronic conditions. Despite its benefits, global physical inactivity is prevalent, contributing to chronic diseases and premature mortality. For patients with chronic kidney disease (CKD) and rheumatoid arthritis (RA), PA is particularly beneficial as it improves endothelial health, reduces cardiovascular risk, diminishes inflammation, and enhances quality of life. Given the chronic inflammation and immune system dysregulation in CKD and RA, PA may mitigate these effects and improve patient outcomes. The primary objective of this study is to evaluate the effects of a personalized aerobic exercise program on cardiovascular risk in patients with CKD or RA. The secondary objectives are to assess the effects on inflammation and immunosenescence; investigate the relationship between inflammation, immunosenescence, and various health outcomes; compare the impacts of chronic PA and PA guidance on cardiovascular risk, disease activity, lifestyle habits, cognitive functions, and quality of life. This study presents an interventional design. A total of 105 subjects are expected to participate in this study, including 45 CKD patients and 45 RA patients. Participants will be stratified by PA level and cardiovascular risk (SCORE 2 scale) and then randomized into three groups: Control Group: 15 CKD and 15 RA patients; Therapeutic Education Group: 15 CKD and 15 RA patients; and Experimental Group: 15 CKD and 15 RA patients. The inclusion criteria are: age \> 50 years; diagnosed with CKD or RA; glomerular filtration rate between 45 and 29 ml/min/1.73 m² for CKD; DAS-28 score ≥ 2.6 for RA; medical clearance for PA; informed consent and affiliation with French social security. The exclusion criteria are: unstable corticosteroid therapy or \>10 mg prednisone/day; uncontrolled hypertension; pregnancy; cognitive impairment preventing adherence to the program; inability to perform PA; legal incapacity or anticipated poor cooperation; lack of health insurance and participation in an incompatible study. The primary efficacy criterion of this study is changes in endothelial function (macrovascular arterial stiffness) and the secondary efficacy criteria are: endothelial function (microvascular hyperemia test); levels of inflammation and immunity (blood tests); physical activity levels and quality of life (questionnaires); disease-related functional impairment; disease activity and cognitive function. Patient screening will begin with the identification of eligible patients in the Nephrology and Rheumatology departments. Day 0 will be the selection visit for participant information and consent. A week after Day 0, the inclusion visit and initial assessment (arterial stiffness, endothelial function, disease impact, and blood markers for immunosenescence and inflammation, blood pressure, heart rate, PA level, quality of life, and cognitive functions) will be conducted for all patients. Next, only the patients in the experimental group will carry out a 47-minute cycling intermittent exercise session, perceived exertion assessment, and post-exercise reassessment. They will redo the assessments after the exercise. They will have another 16 sessions of supervised exercise by a health professional and a final session identical to the first for reassessment. Patients in the physical activity guidance group will not undertake a physical exercise program but will receive one call per week to discuss the physical activities performed and get answers to their questions on the subject. The control group will continue with their usual lifestyle habits.
NCT06151054
Show that there is a relationship between arterial stiffness and aortic parietal inflammation and that this relationship is different in the three age groups with aortic parietal inflammation occurring earlier than arterial stiffness.
NCT05221905
Post-menopausal females experience elevated cardiovascular disease risk (CVD), compared to premenopausal females and age-matched males. Current exercise guidelines appear inadequate to ameliorate this increased risk and higher intensity exercise may be necessary. Oral inorganic nitrate supplementation enhances both exercise performance and CVD risk profile in several clinical conditions. However, the effects of this intervention in post-menopausal females is unexplored.
NCT05866497
Studies were found that a significant relationship between the severe periodontitis and increased CAVI values. While the exact mechanisms linking periodontitis, type 2 diabetes, and cardiovascular disease are not yet fully understood, it is clear that these diseases are interconnected. There are limited data in the literature evaluating the risk of atherosclerosis in diabetic individuals with periodontal disease. In our survey, we hypothesised that severe periodontitis may be a risk factor for the development of subclinical atherosclerosis among people with type 2 diabetes. Thus, we aimed to investigate the potential risk of subclinical atherosclerosis by using a new surrogate marker CAVI in severe periodontitis patients with short-term diabetes.
NCT05719090
To investigate the acute effects of autoregulated (AR) and non-autoregulated (NAR) BFR exercise on indices of arterial stiffness. AR BFR training devices adjust pressure in the cuff ensuring similar pressure throughout the range of motion when the muscles are contracted (dilatated) and relaxed. NAR BFR training devices do not adjust pressure in the cuff throughout the range of motion when the muscles are contracted and relaxed which cause greater pressures at different points in the range of motion. METHODS: Following a randomized AR or NAR familiarization training session, 20 adults (23±5 years; 7 female) participated in 3 randomized treatment-order sessions with AR-BFR, NAR-BFR, and no- BFR separated by 1-week washout periods. Participants performed 4 sets of dumbbell wall squats to failure using 20% of 1 repetition maximum (1-RM) at 2-second concentric/eccentric cadence. Training limb occlusion pressure (LOP) was set at 60% of supine LOP for both the AT and NAR sessions. Testing before and immediately following the training session included ultrasonography of the carotid artery, applanation tonometry, and blood pressure acquisition. Two-way ANOVAs were used to examine the effects of treatment and the treatment-order interaction on pulse wave velocity (PWV), beta-stiffness index (β-stiff), and arterial compliance (AC). RESULTS: There were no baseline differences in CF- (carotid-femoral) PWV, CR- (carotid-radial) PWV, β-stiff, and AC (all p \> 0.05). CF-PWV increased in the NAR-BFR (mean difference = 0.57±1.12 m/s, p = 0.02) and no-BFR (mean difference = 0.63±1.42 m/s, p = 0.03) groups following the exercise session. CR-PWV increased in the no-BFR (mean difference = 0.82±1.5 m/s, p = 0.03) group. And there was an interaction effect in CFPWV between AR-BFR and NAR-BFR (mean difference = 0.70±1.6 m/s, p = 0.03). CONCLUSION: These findings show acute AR-BFR training does not influence indices of arterial stiffness while acute NAR-BRF training increases central stiffness.
NCT04049162
Recent evidence suggests that increased berry intake results in a variety of health benefits, across multiple health domains. This 3-month randomized, double-blind, placebo-controlled trial assess the effects of combining daily blueberry intake with weekly exercise (BB-EX) on cardiovascular function, as well as physical activity and cognitive function, in sedentary older adults (\>60 years). We will compare these effects to the same outcomes with a control group consuming a blueberry placebo (P-EX) at 0, 4, 8 and 12 weeks.
NCT05645991
The goal of this intervention is to determine the efficacy of coconut sap powder (CSP) to lower arterial stiffness and blood pressure in middle-aged and older adults. Participants will be randomized to the CSP arm or Placebo arm of the study. Primary endpoints include: aortic stiffness assessed by carotid-femoral pulse wave velocity, resting brachial and (non-invasive) carotid blood pressure, and carotid stiffness (e.g. Beta stiffness index, Carotid compliance, Elastic modulus, Distensibility).
NCT04511325
The investigators are examining the effects of potato consumption on indices of glycemic control and cardiovascular health in overweight and obese individuals with type two diabetes mellitus (T2D) to provide feasible and effective dietary ways for individuals to enhance their quality of life. The overall objective of this crossover study is to collect data regarding the effects of potato consumption on indices of glycemic control and cardiovascular health among overweight and obese individuals with T2D. The central hypothesis of this crossover study is that the daily consumption of 100 g white potato for 12 weeks will contribute to improvements in glycemic control, reductions in inflammation, and improvements in blood lipids and vascular function in overweight and obese individuals with T2D compared to a macronutrient-matched refined grain (75 g cooked long-grain white rice) for 12 weeks (with a 2 week washout period between interventions). Specific Aim) The assessment of blood glucose control, vascular function, body composition and overall cardiovascular risk after consumption of potatoes (100g/d for 12 weeks) in individuals with T2D compared to a calorie matched refined grain at the initial baseline visit as well as the 6-, and 12-week study visits (for each 12-week intervention period). This aim will assess changed in blood glucose, insulin, HbA1c, HOMA-IR, and HOMA-β as well as the following: 1. blood pressure (BP) 2. markers of endothelial function \[flow-mediated dilation (FMD), pulse wave velocity (PWV), and endothelin-1 (ET-1)\] 3. markers of inflammation (C-reactive protein) 4. body composition via bioelectrical impedance (BIA), lean mass and fat mass assessment 5. lipid profiles, consisting of total cholesterol (TC), triglycerides (TG), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C) and oxidized LDL (Ox-LDL). Atherogenic risk ratios (TC/HDL-C, LDL-C/HDL-C, HDL-C/LDL-C) will also be assessed 6. anthropometrics \[weight, height, waist circumference (WC), hip circumference (HC), waist-to-hip ratio (WC/HC)\]
NCT04862754
this study is aiming to assess the chronic effect of the interval training program on arterial stiffness in women with hypertension
NCT04532385
The main objectives of this study were to evaluate the effect of a 12-week supplementation with GTE (400 mg every 12 hours) on serum lipids, arterial stiffness and inflammatory cytokines in patients with T2DM.
NCT01579032
The aims of the presented study are as follows: 1. To evaluate the endothelial function and arterial stiffness in a large cohort of prevalent CKD patients by means of non-invasive applantion tonometry. 2. To evaluate the association between the serum levels of the representatives of the various classes of uremic toxins and markers of endothelial function and arterial stiffness. 3. To evaluate the association between markers of inflammation and oxidative stress and markers of endothelial function and arterial stiffness. 4. To evaluate the association between echocardiographic parameters and markers of arterial stiffness
NCT03560804
The principal aim of the study is to determine whether the hemodynamic parameters measured with the two methods -impedance cardiography and applanation tonometry- can be predictive of the antihypertensive effect of two different classes of drugs, ATII antagonists and diuretics. The drugs that will be used in the study are olmesartan and chlorthalidone and the duration of the study is 12 months. The other basic aim of the study is to determine whether there is a difference (\>6mmHg) between the two drugs regarding the reduction of the mean 24hour blood pressure and the effect of them on the hemodynamic parameters. The hemodynamic parameters that will be measured by applanation tonometry are augmentation index, central blood pressure and pulse wave velocity. The hemodynamic parameters that will be measured by impedance cardiography are cardiac index, thoracic fluid content index, systemic vascular resistance index and others.